{"product_id":"clinical-research-principles-practice-and-regulation-9798903622238","title":"Clinical Research: Principles, Practice, and Regulation","description":"\u003cp\u003e • Author(s): Dr Thalugula Sunitha | Dr Nerella Mounika | Rajesh Oruganti\u003cbr\u003e • Publisher: Notion Press\u003cbr\u003e • Publisher Imprint: Notion Press\u003cbr\u003e • BISAC: Research\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eClinical Research: Principles, Practice, and Regulation\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003eModern medicine depends on clinical research to transform scientific discovery into safe and effective therapies. Behind every approved treatment lies a complex system of study design, ethical oversight, regulatory evaluation, and rigorous data analysis.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eClinical Research: Principles, Practice, and Regulation\u003c\/strong\u003e explores how this system works-from the earliest stages of drug discovery to the conduct of clinical trials and the regulatory decisions that bring new therapies to patients. T\u003cstrong\u003ehe book examines the scientific and ethical questions that guide modern investigation: \u003c\/strong\u003e \u003cstrong\u003eHow are clinical trials designed to generate reliable evidence? How are risks balanced against potential benefits for participants? What role do ethics committees, investigators, sponsors, and regulators play in safeguarding research integrity?\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003eDrawing on global standards such as \u003cstrong\u003eGood Clinical Practice and international regulatory frameworks, the book explains the structure of Phase I-IV trials, real-world evidence generation, safety monitoring, and data governance. Operational aspects-including trial organization, monitoring, documentation, and regulatory inspections-\u003c\/strong\u003eare also examined.\u003c\/p\u003e\u003cp\u003eWritten for \u003cstrong\u003epostgraduate students, researchers, investigators, and clinical trial professionals, \u003c\/strong\u003e this book provides a c\u003cstrong\u003elear view of the scientific, ethical, and regulatory foundations that shape modern clinical research.\u003c\/strong\u003e\u003c\/p\u003e","brand":"Notion Press","offers":[{"title":"Hardcover","offer_id":47812965171351,"sku":"9798903622238","price":4520.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9798903622238.webp?v=1778332543","url":"https:\/\/atlanticbooks.com\/products\/clinical-research-principles-practice-and-regulation-9798903622238","provider":"Atlantic Books","version":"1.0","type":"link"}